FDA Finally Gets Around to Approving Pfizer’s Anti-COVID Pill

U.S. Food and Drug Administration announced today that the FDA has issued an EUA for Pfizer’s Paxlovid oral antiviral medication Paxlovid to treat COVID-19.

Pfizer announced earlier in the month that it had found that the drug reduced hospitalization and death rates by 89% and 88%, respectively (within 3 days of symptoms onset), respectively. There were no deaths in this trial. The medication was also less likely to cause complications than placebo for non-hospitalized high-risk patients with COVID-19. Paxlovid combines the ritonavir HIV inhibitor with a protease inhibitor new to the treatment. It targets a specific enzyme required for the coronavirus and the omicron variants to grow and replicate.

The FDA delayed issuing an EUA despite Pfizer’s decision to stop enrolling people in its clinical trials in early November. This was because Pfizer believed the treatment would prove so efficient that it wouldn’t have been ethical to offer placebos to anyone else. Between then and now, the number of COVID-19-related deaths increased by 50,000.

Children and adults over 12 should not be given the pill if they are positive for COVID-19. This is because it increases your risk for severe illness, hospitalizations or even death. It is important to begin treatment as soon after receiving a COVID-19 diagnose and as soon thereafter as possible. The problem is compounded by the FDA’s huge oversight in delaying approval of quick at-home COVID-19 testing. Many people won’t be able to get the test in the time necessary to inform them that Pfizer could help.

Pfizer received $5B from the Biden administration for 10 million Paxlovid courses. This was four weeks ago. However, The New York Times is reporting that Pfizer is expected to deliver only enough of its pills to cover 65,000 Americans within the next week. The following is the TimesThis is insufficient at present infection rates to provide treatment for half the U.S. people who are positive. Pfizer is able to provide 200,000 doses of treatment for January, and another 150,000 in February. But every bit counts.